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Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)

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ClinicalTrials.gov Identifier: NCT01720823
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.

Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: home polysomnography (GETEMED) Device: standard polysomnography (BRAINNET II) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study
Study Start Date : October 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: home polysomnography and standard polysomnography
home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.
Device: home polysomnography (GETEMED)
Other Name: GETEMED
Device: standard polysomnography (BRAINNET II)
Other Name: BRAINNET II



Primary Outcome Measures :
  1. Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children. [ Time Frame: 1 night ]
    • Standard polysomnography considered pathological if obstructive apnea-hypopnea index (AHI) > 5 / hr.
    • Home polysomnography considered pathological if at least one of the following criteria is present :

      1. Respiratory Disturbance Index (RDI) > 10 / hr + /- Desaturation Index > 4% for more than 2.5 / hr.
      2. Brouillette index ; pulse wave > 3 desaturation clusters and > 3 desaturation <90%.


Secondary Outcome Measures :
  1. To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography. [ Time Frame: 1 night ]


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects, aged 2 to 6 years old, requiring a polysomnography or admitted for intense snoring or suspected sleep apnea
  • Parents must have signed the inform consent form and be covered by the National Health Insurance Program.

Exclusion Criteria:

  • Parents opposed to the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720823


Locations
France
Hospices Civils de Lyon- Hôpital Femme Mère Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Patricia FRANCO, MD Hospices Civils de Lyon- Hôpital Femme Mère Enfant

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01720823     History of Changes
Other Study ID Numbers: 2009.589
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016

Keywords provided by Hospices Civils de Lyon:
Obstructive Sleep Apnea syndrome
polysomnography
Home monitoring

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases